IP Law Daily, PATENT—Fed. Cir.: Patents not infringed where ANDA proposes a use not covered by the patents, (Dec 7, 2023)

By Robert B. Barnett Jr., J.D.

Mere knowledge of possible infringement by others, the appellate court said, does not amount to inducement in the absence of specific intent and action to induce infringement.

The Federal Circuit has affirmed a Delaware district court’s ruling that Lupin Pharmaceuticals’ ANDA did not infringe two patents held by Takeda Pharmaceuticals on the antidepressant drug vortioxetine because Lupin validly sought approval for a use that was different from the two uses covered by the patents. In doing so, the Federal Circuit rejected Takeda’s argument that infringement occurs under 35 U.S.C. §271(e)(2)(A) as long as the drug could be prescribed for those patented uses, even if the ANDA applicant has stated that it has no intention of marketing the drug for those uses. The appellate court also, however, affirmed the Delaware court’s conclusion that Lupin’s production of its generic version would infringe one of Takeda’s patents for the making of vortioxetine (H. Lundbeck A/S v. Lupin Ltd., December 7, 2023, Dyk, T.).

Background. Takeda U.S.A. Inc. hold a patent for the branded drug Trintellix for the treatment of major depressive disorder (MDD) in adults. Its active ingredient is a salt of vortioxetine. Takeda holds U.S. Patent Nos. 7,144,884 (the drug compound) and 8,476,279 (a method of use for treating depression). After FDA approval of Trintellix to treat MDD, Takeda also secured U.S. Patent No. 9,278,096 (the ’096 patent) to treat patients who have previously taken other antidepressants and had experienced sexual dysfunction and U.S. Patent No. 9,125,910 (the ’910 patent) to treat cognitive impairment, another common effect of MDD. Both patents were listed in the FDA’s Orange Book, with expiration dates in 2032 and 2027, respectively.

Lupin submitted its Abbreviated New Drug Application (ANDA) to the FDA for approval to market vortioxetine for only one indication—the treatment of MDD in adults, which was not covered by either the ’096 patent or the ’910 patent. ANDA applicants that want to market a drug before expiration of the patents have two options: (1) argue that the patent is invalid or (2) argue that the generic version will be marketed for a use not covered by the existing patents. Lupin chose the second route.

Takeda sued Lupin to enjoin it from marketing a generic form of Trintellix until after the ’096 patent and the ’910 patent had expired. The complaint alleged that Lupin was guilty of induced and contributory infringement of the ’096 patent and that it was guilty of contributory infringement of the ’910 patent. Following a bench trial, the district court ruled that Lupin had not induced or contributed to infringement for either patent. Takeda appealed the decision.

Meanwhile, Takeda also held Patent No. 9,101,626 (the ’626 patent), which covered a process for making vortioxetine. Takeda alleged in its lawsuit that Lupin’s proposed process for making vortioxetine would infringe claim 12 of the ’626 patent. The district court agreed with Takeda that Lupin would infringe the ’626 patent, with the dispute revolving around disagreements about the construction of the term “reacting.” Lupin cross-appealed the decision.

Direct infringement. Takeda argued on appeal that Lupin’s ANDA infringed its patents because Lupin’s labels on the generic did not prohibit prescribing vortioxetine for uses covered by the ’096 patent and the ’910 patent. The Federal Circuit characterized Takeda’s argument as follows: It makes no difference that the drug is proposed to be sold for a use not covered by the ’096 and ’910 patents because the drug could be prescribed for those patented uses. “We disagree” with that proposition, the appellate court said.

Case law, the Federal Circuit went on to say, clearly establishes that the claimed use under the patent must be the use for which an applicant is seeking marketing approval. In Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) and its progeny, the Federal Circuit had said, “we considered and rejected plaintiffs’ interpretation of section 271(e)(2)(A).” The “use” in §271(e)(2)(A) refers to the use for which the ANDA was submitted. It is not an act of infringement, the court noted, “to submit an ANDA for a drug if just any use of that drug were claimed in a patent.” Otherwise, the goals of the Hatch-Waxman Act for speeding up generic substitutes would be thwarted.

In addition, under this interpretation, Takeda’s rights are still protected. If Lupin were to market its generic for a reason not stated in the ANDA, Lupin would violate the ANDA and open itself up for liability for that violation. As a result, Takeda failed to establish that §271(e)(2)(A) provides an independent basis of infringement. The appellate court, therefore, ruled that the district court did not err when it found that Lupin sought approval to market the drug for the treatment of MDD that was not covered under patents ’096 or ’910.

Induced infringement. Takeda argued on appeal that the trial court erred when it found that Lupin was not guilty of induced infringement of the ’096 patent under 35 U.S.C. §271(b). The Federal Circuit, however, noted that induced infringement requires that the inducer must have “knowingly aided and abetted” direct infringement, which involves taking steps to encourage, recommend, or promote infringement. No such evidence existed to support that argument. Once again, Takeda relied solely on the argument that inducement arose from the proposed ANDA labels. The fact that the possibility exists that clinicians may prescribe the generic drug for uses outside the ANDA did not constitute induced infringement, absent some effort on Lupin’s part to encourage the off-use. And once again, interpreting the law in such a way would thwart the purposes of the Hatch-Waxman Act. According to the Federal Circuit, Takeda’s infringement theory “depends entirely on the ‘Adverse Reactions’ section of the defendants’ ANDA label.” These adverse reactions, however, have been on the Trintellix label since the FDA first approved Trintellix, which was years before the patent was obtained. And Lupin is required to have them on its label if it wants ANDA approval.

Rejection of that theory, the appellate court noted, left Takeda with only two arguments on inducement: (1) the ANDA label induces physicians to prescribe the generic drug for reasons covered by the patents because the physicians will know about those covered uses and (2) the district court erred when it ignored 5 mg, 10 mg, and 15 mg doses and failed to cite any record evidence of them. The Federal Circuit rejected both theories. First, Lupin cannot be held responsible for what some physicians armed with that knowledge might do or not do. Lupin does not commit inducement when a physician acts on his or her own to go off-label. Second, the Federal Circuit concluded that the district court “relied on multiple sources of evidence” to apply its ruling to all dosage forms. The court did not err when it relied on evidence about the recommended dose in addition to evidence that applies equally to all doses.

Contributory infringement. Takeda also argued on appeal that Lupin committed contributory infringement whenever it sold its generic product because physicians will prescribe them in accordance with the methods claimed in the ’096 and ’910 patents. But under 35 U.S.C. §21(c), the appellate court noted, no contributory infringement exists for selling a drug that is “suitable for substantial noninfringing use.” In this case, the Federal Circuit said, substantial noninfringing use existed.

The Federal Circuit also agreed with the lower court in rejecting Takeda’s argument that contributory infringement could exist if the noninfringing uses violated some other patents that Takeda’s parent, Lundbeck, owned. Liability under §271(c) does not extend that far, the court said. Liability applies only to the patent in question. To be liable, Lupin must sell its generic version knowing that an adapted use will infringe the patent in question. It was not error, the Federal District concluded, for the district court to rule that Lupin had no such knowledge and intent.

Cross-appeal. Having rejected Takeda’s appeal, the Federal Circuit moved to Lupin’s cross-appeal on the finding that Lupin had violated the ’626 patent in how the generic was to be made. In reaching its decision, the district court had chosen Takeda’s definition of “reacting” rather than Lupin’s definition, which was narrower. Reviewing the matter de novo, the appellate court agreed with the district court’s decision. Nothing in the claim, the Federal Circuit said, supported Lupin’s narrower definition. As a result, the Federal Circuit affirmed the lower court’s ruling that Lupin’s method for producing its generic drug would infringe the ’626 patent.

The Federal Circuit, therefore, affirmed the district court’s ruling in its entirety.

The Case is Nos. 2022-1194, 2022-1208, and 2202-1246.

Attorneys: Brianne Bharkhda (Covington & Burling LLP) for H. Lundbeck A/S, Takeda Pharmaceutical Co Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International AG and Takeda Pharmaceuticals America, I. Deepro Mukerjee (Katten Muchin Rosenman LLP) for Lupin Ltd. and Lupin Pharmaceuticals, Inc. David B. Abramowitz (Locke Lord LLP) for Alembic Global Holding S.A., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Cadila Healthcare Ltd. and Lek Pharmaceuticals, d.d., Macleods Pharma USA, Inc., Macleods Pharmaceuticals Ltd., Sandoz Inc., Sigmapharm Laboratories, LLC, Zydus Pharmaceuticals [USA] Inc. Cadila Healthcare Ltd., and Zydus Pharmaceuticals [USA] Inc. Bradley C. Graveline (Sheppard Mullin Richter & Hampton LLP) for Alembic Global Holding S.A., Alembic Pharmaceuticals Inc., and Alembic Pharmaceuticals Limited. Mary LaFleur (Crowell & Moring, LLP) for Lek Pharmaceuticals, d.d., Macleods Pharma USA, Inc., Macleods Pharmaceuticals Ltd. and Sandoz Inc.

Companies: H. Lundbeck A/S; Takeda Pharmaceutical Company Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals International AG; Takeda Pharmaceuticals America, I; Lupin Ltd.; Lupin Pharmaceuticals, Inc.; Macleods Pharma USA, Inc.; Macleods Pharmaceuticals Ltd.; Sandoz Inc.; Sigmapharm Laboratories, LLC; Zydus Pharmaceuticals (USA) Inc.; Alembic Global Holding S.A.; Alembic Pharmaceuticals Inc.; Alembic Pharmaceuticals Ltd.; Cadila Healthcare Ltd.; Lek Pharmaceuticals, d.d.

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